Mobile medical apps are mobile apps that meet the definition of a “device” which are intended either: 1- To be used as an accessory to a regulated m...

Further, according to FDA, a “general wellness product” falls into one of two categories, and either: Has (1) an intended use that relates to a maint...

I think it all comes down to communication and accountability. The team should have some sort of idea what the others are working on. Another thing of...

I found too many companies charged for illegal kickbacks violations for example: 1- In North Carolina, Minneapolis-based Cardiovascular Systems, Inc....

YES you can start your project based on a verbal agreement, but you need to make a prove for this verbal agreement, but if you failed to prove the agr...

I think every one studying BME should take this class. I have learned a lot about medical device development. This course helped me to learn a lot abo...

Middle Manager, I think 'middle managers' are an employer's most important leaders .Although middle managers may be work under increased pressure and ...

I think Project-based Organization manager is better than being a manager in a matrix-organization. A project-based organization manager have a lot of...

I would like to work in matrix-organization, which all departments work closely together and communicate with each other frequently to solve issues (t...

As we have learned, Risk Management is done on multiple areas of a project, not just one:The product, The product design, and The manufacturing proces...

A key for each medical device company is: Keeping up with changes to ISO 13485: " specifies requirements for a quality management system where an org...

Example For Verification process: If you said in Design Input Requirements " The MRI machine’s electrical system shall operate at 120V at less than 16...